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Normas industriales

Aligned with the standards
your industry runs on

See how Modern Requirements4DevOps maps directly to the controls, features, and evidence that leading compliance frameworks require — all inside Azure DevOps.

SOC2 ISO 9001 ISO 9000 ISO 26262 CFR Part 11 ISO 13485 ISO 14971 ISO 17491 ASPICE

Standards Library

Learn how MR4DevOps aligns with popular standards

Practical guides and references for managing compliance across the frameworks regulated teams depend on every day.

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ISO 26262

Gestión del cumplimiento de la norma ISO 26262 con los requisitos actuales

Easily manage ISO 26262 compliance while accelerating your development cycle.

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ASPICE

Gestión del cumplimiento de ASPICE con los requisitos actuales

Managing ASPICE compliance with Modern Requirements for automotive software performance improvement.

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21 CFR Part 11

21 CFR Parte 11: Preguntas frecuentes

A 21 CFR Part 11 questions-and-answers blog by Modern Requirements.

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Medical Devices

Facilitate the Medical Device Design Controls with Modern Requirements

Achieve quicker compliance, shorter development cycle times, and faster value delivery.

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ISO 17491

Managing ISO 17491 Compliance within Azure DevOps using Modern Requirements

Comply with ISO 17491 in an automated and efficient manner.

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ISO 9001:2015

Modern Requirements cuenta con la certificación ISO 9001:2015

We are committed to quality assurance and exceeding customer expectations.

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At a Glance

Standards we cover

Jump straight to the compliance matrix for any framework below.

SOC2
General ↓ ISO 9001
General ↓ ISO 9000
General ↓ ISO 26262
General ↓ CFR Part 11
Medical ↓ ISO 13485
Medical ↓ ISO 14971
General ↓ ISO 17491
General ↓ ASPICE
Automotive & Manufacturing ↓

Matriz de cumplimiento

Every requirement, mapped to a feature

For each standard: the relevant feature area, what it demands, and the Modern Requirements4DevOps capability that delivers it.

Estándar

SOC2

General

This is a standard for service organizations that handle customer data. SOC2 requires that organizations establish and maintain a system of controls to ensure the confidentiality, integrity, and availability of customer data. Requirements management is an important part of these controls, as it ensures that customer requirements for data handling and protection are met.

Relevant feature	Feature description	MR4DevOps feature
Control de acceso	Access controls to ensure that only authorized users can access data. Access controls should be in place to ensure that only authorized individuals are granted access to view or modify requirements or other sensitive data.	Smart DocsCoPilot4DevOps
Recopilación de requisitos	Ability to gather and document requirements from stakeholders, including identifying the needs and expectations of the system or service under review.	Smart DocsFAQ
Gestión de requisitos	Ability to manage and maintain the requirements throughout the development process, including version control, change management, and approval workflows.	VersioningImpact AssessmentApproval
Trazabilidad	Ability to establish and maintain traceability between requirements and other project artifacts, such as design, testing, and documentation.	Matriz de trazabilidad
Pruebas	Ability to design and execute tests to verify that the system or service under review meets the requirements and specifications.	Centro de pruebas
Documentación	Ability to document the requirements, design, testing, and other project artifacts in a clear and concise manner.	Smart DocsSimulationSmart ReportsSmart NoteEmail
Seguridad	Ability to ensure the security and confidentiality of the requirements and other project artifacts, as well as the system or service under review.	Security and Access Control
Colaboración	Ability to enable collaboration among team members and stakeholders, including sharing and discussing project artifacts.	Smart DocsSimulationSmart ReportsSmart NoteEmailReview
Auditoría	Audit logging to record any changes made to requirements. Audit logs should be maintained to provide an audit trail and flag all changes made to requirements, including who made the change and when it was made.	Traceability MatrixReview
Informes	Reporting capabilities to provide evidence of compliance. The requirements management tool should be able to produce reports that provide evidence of compliance with SOC2, such as reports on access controls or audit logs.	Informes inteligentes

Estándar

ISO 9001

General

This is an international standard for quality management systems. It requires that an organization establish a process for managing its requirements and ensure that they are met throughout the product or service lifecycle.

Relevant feature	Feature description	MR4DevOps feature
Trazabilidad	Capacidad para rastrear los requisitos hasta su origen.	Matriz de trazabilidad
Gestión del cambio	Capacidad para realizar un seguimiento y gestionar los cambios en los requisitos.	VersioningImpact AssessmentApproval
Control de versiones	Posibilidad de realizar un seguimiento de las versiones de los requisitos.	VersioningImpact AssessmentBaseline
Gestión de la línea de base	Capacidad para gestionar y realizar un seguimiento de los requisitos aprobados.	Línea de base
Análisis de requisitos	Capacidad para analizar y validar requisitos.	Análisis de requisitos
Requisitos Colaboración	Capacidad para colaborar y compartir requisitos.	Smart DocsSimulationSmart ReportsSmart NoteEmail
Informes sobre requisitos	Capacidad para generar informes sobre los requisitos.	Informes inteligentes

Estándar

ISO 9000

General

ISO 9000 requires that organizations establish a process for managing their requirements and ensure that they are met throughout the product or service lifecycle.

Relevant feature	Feature description	MR4DevOps feature
Requisitos documentados	The organization must establish and maintain documented requirements for its products or services, including those related to quality.	Smart DocsSmart NoteEmail
Revisión de los requisitos	The organization must review the documented requirements before they are finalized to ensure that they meet the customer's needs.	ReviewApproval
Validación de requisitos	The organization must validate the requirements to ensure that they are complete, correct, and unambiguous.	FAQCoPilot4DevOpsReviewApproval
Cambios en los requisitos	The organization must have a process in place for managing changes to the documented requirements.	BaselineVersioningImpact Assessment
Trazabilidad de los requisitos	The organization must establish and maintain traceability between the requirements and the product or service design and development stages.	Traceability MatrixCoverage Analysis
Verificación de requisitos	The organization must verify that the product or service meets the documented requirements.	Test HubReviewApproval
Aceptación de los requisitos	The organization must obtain customer acceptance of the product or service in accordance with the documented requirements.	Test HubReviewApproval

Estándar

ISO 26262

General

ISO 26262 requires that organizations establish a process for managing the safety requirements of their systems, including the management of safety requirements throughout the development lifecycle.

Relevant feature	Feature description	MR4DevOps feature
Trazabilidad	Ability to trace requirements and their implementation throughout the development process.	Matriz de trazabilidad
Gestión de la línea de base	Ability to manage multiple versions of requirements and their associated artifacts.	Línea de base
Gestión del cambio	Ability to manage changes to requirements and associated artifacts throughout the development process.	Change ManagementVersioningImpact Assessment
Revisión y aprobación	Ability to review and approve requirements and associated artifacts prior to implementation.	ReviewApproval
Validación de requisitos	Ability to validate requirements and ensure they are complete, consistent, and unambiguous.	FAQCoPilot4DevOpsReviewApproval
Reutilización de requisitos	Ability to reuse requirements across multiple projects or products.	Reutilización de requisitos
Priorización de requisitos	Ability to prioritize requirements based on their importance and impact on the system.	Priorización de requisitos
Informes sobre la trazabilidad de los requisitos	Ability to generate reports that show the traceability of requirements and their implementation throughout the development process.	Análisis de trazabilidad
Análisis del impacto de los cambios en los requisitos	Ability to analyze the impact of changes to requirements on the system and its associated artifacts.	Evaluación de impacto

Estándar

CFR, Parte 11

Médico

This is a regulation that governs electronic records and signatures in the pharmaceutical and medical device industries. CFR Part 11 requires that organizations manage their requirements for electronic records and signatures and ensure that they are accurate, complete, and secure.

Relevant feature	Feature description	MR4DevOps feature
Registros electrónicos	Ability to manage electronic records in a secure, reliable, and auditable manner.	Electronic Records Management
Firmas electrónicas	Ability to capture and manage electronic signatures in a secure, reliable, and auditable manner.	Firmas electrónicas

Estándar

ISO 13485

Médico

ISO 13485 requires that organizations establish a process for managing the requirements for their medical devices and ensure that they are safe, effective, and meet regulatory requirements.

Relevant feature	Feature description	MR4DevOps feature
Gestión de riesgos	Risk management capabilities to identify and manage risks related to medical device requirements. The tool should provide risk management capabilities that allow risks related to medical device requirements to be identified and managed.	Smart DocsBaselineRequirements ReuseTraceability AnalysisMatCal
Trazabilidad	Ability to trace requirements and their implementation throughout the development process.	Matriz de trazabilidad
Planificación del diseño y el desarrollo	Ability to plan and manage the design and development process, including requirements management and verification.	SimulationDiagrammingUsecase
Aportaciones al diseño	Ability to capture and manage requirements and input from stakeholders and other sources.	FAQEmail
Resultado del diseño	Ability to manage design output and ensure that it meets all applicable requirements and specifications.	Centro de pruebas
Verificación y validación del diseño	Ability to verify and validate the design to ensure that it meets all applicable requirements and specifications.	ReviewApproval
Cambios en el diseño	Ability to manage changes to the design throughout the development process, including their impact on other requirements and specifications.	BaselineVersioningImpact Assessment
Control de documentos	Ability to manage documents and records associated with the product or service in a controlled and auditable manner.	Smart DocsSmart NoteSmart Reports
Gestión de proveedores	Ability to manage suppliers and ensure that they meet all applicable requirements and specifications.	Gestión de proveedores
Formación y competencias	Ability to provide training and ensure the competence of personnel involved in the design, development, and production or service delivery process.	ReviewApproval
Gestión de documentos	Document management capabilities to manage documentation related to medical device requirements: the tool should provide document management capabilities that allow documentation related to medical device requirements to be managed and tracked.	Smart DocsSmart Note

Estándar

ISO 14971

General

ISO 14971 requires that organizations establish a process for managing the requirements for risk management and ensure that risks are identified, analyzed, evaluated, and controlled throughout the product lifecycle.

Relevant feature	Feature description	MR4DevOps feature
Gestión de riesgos	The tool needs to identify and manage risks related to the safety of medical devices throughout the development process, including the use of risk analysis techniques and risk management plans.	Smart DocsBaselineRequirements ReuseTraceability MatrixMatCal
Análisis de riesgos	Ability to analyze and evaluate risks associated with medical devices, including identifying hazards and assessing their severity and probability of occurrence.	Evaluación de impacto
Vigilancia posterior a la comercialización	Ability to monitor and report on the performance and safety of medical devices after they have been released to the market.	Centro de pruebas
Información sobre la producción y la posproducción	Ability to manage information related to the production and post-production of medical devices, including changes to the device and any associated risks.	BaselineVersioningImpact Assessment
Control de documentos	Ability to manage documents and records associated with medical devices in a controlled and auditable manner.	Documentos inteligentes
Trazabilidad	Ability to trace requirements and their implementation throughout the development process, including the identification of risks and risk control measures.	Matriz de trazabilidad
Planificación del diseño y el desarrollo	Ability to plan and manage the design and development process for medical devices, including requirements management and verification.	SimulationDiagrammingUsecase
Aportaciones al diseño	Ability to capture and manage requirements and input from stakeholders and other sources for medical devices.	FAQEmail
Funciones de trazabilidad	The tool needs to enable the linking of safety requirements to other requirements and work products to ensure that safety requirements are met.	Vinculación de elementos de trabajo
Funciones de generación de informes	The tool needs to provide evidence of compliance with ISO 14971 by generating reports on risk management activities.	Informes inteligentes

Estándar

ISO 17491

General

ISO 17491 specifies a test method for determining the resistance of protective clothing against penetration by chemicals.

Relevant feature	Feature description	MR4DevOps feature
Funciones de trazabilidad	The tool needs to enable the linking of software requirements to system requirements and design to ensure that software requirements are met.	Matriz de trazabilidad
Documentación de requisitos	Ability to document requirements in a clear and concise manner.	Smart DocsCoPilot4DevOps
Planificación del diseño y el desarrollo	Ability to plan and manage the design and development process for medical devices, including requirements management and verification.	SimulationDiagrammingUsecase
Funciones de generación de informes	The tool needs to provide evidence of compliance by generating reports on risk management activities.	Informes inteligentes
Gestión del cambio	Ability to manage changes to project artifacts, including requirements, design, and code.	Línea de base

Estándar

ASPICE

Automotive & Manufacturing

(Automotive Software Process Improvement Capability dEtermination) is an industry-standard guideline for evaluating software development processes.

Relevant feature	Feature description	MR4DevOps feature
Funciones de trazabilidad	The tool needs to enable the linking of software requirements to system requirements and design to ensure that software requirements are met.	Matriz de trazabilidad
Determinación de requisitos	Ability to identify, collect and document requirements from stakeholders.	FAQEmail
Análisis de requisitos	Ability to analyze requirements for consistency, completeness, feasibility, and testability.	ReviewApproval
Documentación de requisitos	Ability to document requirements in a clear and concise manner.	Smart DocsCoPilot4DevOps
Gestión de requisitos	Ability to manage changes to requirements, including version control and approval workflows.	VersioningApproval
Verificación de requisitos	Ability to verify that requirements have been implemented correctly and meet the specified criteria.	Centro de pruebas
Gestión del cambio	Ability to manage changes to project artifacts, including requirements, design, and code.	BaselineVersioningImpact Assessment
Métricas y análisis	Ability to collect and analyze metrics related to project progress, quality, and efficiency.	Métricas y análisis
Colaboración	Ability to enable collaboration among team members and stakeholders, including sharing and discussing project artifacts.	Smart DocsSimulationSmart ReportsSmart NoteEmailReview
Configuración	The tool needs to control and document changes to software requirements, including who made the changes and why.	Evaluación de impacto
Planes de pruebas	Capability to manage work products related to software requirements: the tool needs to provide support for work products related to software requirements, such as test plans and test cases.	Centro de pruebas

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Add Your Heading Text Here

Learn how MR4DevOps aligns with popular standards

Gestión del cumplimiento de la norma ISO 26262 con los requisitos actuales

Gestión del cumplimiento de ASPICE con los requisitos actuales

21 CFR Parte 11: Preguntas frecuentes

Facilitate the Medical Device Design Controls with Modern Requirements

Managing ISO 17491 Compliance within Azure DevOps using Modern Requirements

Modern Requirements cuenta con la certificación ISO 9001:2015

Standards we cover

Every requirement, mapped to a feature

Ready to make your next audit audit-ready?

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